MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; APHERESIS SYSTEM

Model Number LA-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Unspecified Kidney or Urinary Problem (4503); Swelling/ Edema (4577)

Event Date 11/19/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 the patient received treatment with liposorber la-15 system.The treatment was completed.At 4:00pm the patient was admitted to the hospital for anasarca with worsening aki exacerbated by dehydration in the setting of elevated cyclosporine levels.The site noted that the sae is possibly related to the treatment and that the device did not malfunction.On (b)(6) 2020, the site reported the sae, classified the adverse event as serious, and noted that the patient was still hospitalized.On 11/30/2020, user facility reported la-15 system lot and serial numbers.They reported that the adverse event has ended on (b)(6) 2020, and that the patient would be continuing treatment with the liposorber system.User facility reported actions taken to treat adverse event as the following medications; cyclosporine held, fluconazole held, lasix oral and iv, and 25% albumin.Mfr#: 3002808904-2020-00021.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 11036537
• MDR Text Key: 222634521
• Report Number: 2435151-2020-00003
• Device Sequence Number: 1
• Product Code: PBN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LA-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 16 YR
• Patient Weight: 67